Ranbaxy Laboratories is putting all of its weight behind a quality push following its admission of manufacturing adulterated drugs, and just as its parent company Daiichi Sankyo is pursuing legal action.

The latest quality efforts follow Ranbaxy's agreement to pay $500M
to the US Department of Justice after lying to the FDA, manipulating data on its manufacturing processes and knowingly manufacturing adulterated drugs. The full back story of how Ranbaxy was able to dupe the FDA, and how the whistleblower unveiled the bulk of the mess was detailed recently
in a long exposé.

But rather than see the quality issues blow over, as Ranbaxy might have liked, a new controversy has sprouted.

Daiichi Sankyo, which acquired Ranbaxy in 2008, released a short statement last week saying that it believes “certain former shareholders of Ranbaxy concealed and misrepresented critical information concerning the U.S. DOJ and FDA investigations.” The Japanese company also said it is “currently pursuing its available legal remedies.”

In response to the Daiichi comments, the Singh family, which were the founders and primary shareholders of Ranbaxy before the takeover, issued a statement taking issue with them. Specifically, the Singh family said Daiichi Sankyo's “allegations of concealment and misrepresentation are false and baseless.”

“At every step of the way during the negotiation process, Daiichi Sankyo and its representatives were made aware of the on-going US FDA and DOJ investigations. They were also given full access to the documents at Ranbaxy pertaining to US FDA and DOJ investigations,” the family statement continued.

Further proof that Daiichi did not take issue with the quality controls of the company, the statement notes that as late as April 2012, Malvinder Singh, former chairman and CEO of Ranbaxy, was invited by the company to attend a new product launch. Noriaki Ishida, a spokesman for Daiichi, would not respond to the statement released by the Singh family.

In addition to potential legal problems, the company could also face a Corporate Integrity Agreement with the US Department of Health & Human Services Office of Inspector General. Such an agreement
typically runs for about five years and means the company’s products would be excluded from US Medicare and Medicaid programs.

Ranbaxy Remediation Efforts

Until that fracas can play out in the courts, Ranbaxy is attempting a full-court press on how its remediation efforts will lead to significant quality improvements and ensure future products are safe and effective.

But Ranbaxy spokesman Chuck Caprariello told In-Pharmatechnologist.com that the company does not know when the consent decree
will be resolved and that it depends on further FDA inspections of the sites. However, he said the majority of the products manufactured at the two Indian sites under the decree were transferred to the company’s two manufacturing sites in New Jersey. He also noted that the company’s API site in India has not been affected by the consent decree.

Since the consent decree, the New Jersey sites have also seen more than $300M in investments to increase capacity three-fold, Caprariello said.

As far as Paonta Sahib and Dewas manufacturing facilities, the company retained independent cGMP auditors, including former FDA employees, to conduct a review of manufacturing practices and certify that all facilities, methods and controls used to manufacture drugs are in compliance with cGMP requirements.

An independent data integrity expert will also conduct a review of the information in past FDA applications from the two facilities and evaluate their reliability and integrity.

In addition, the company appointed VP Manjeet Bindra as the company’s new Chief Data Reliability Officer, which was part of the decree agreed to with the US FDA. Caprariello said Bindra is working full time on the company’s quality improvements and that “he’s a diligent, reserved and quiet man.”

“[Bindra’s] office is very involved in ensuring everything that goes to the FDA meets all of the qualifications, especially because of the historical concerns,” Caprariello said.

Ranbaxy Laboratories is putting all of its weight behind a quality push following its admission of manufacturing adulterated drugs, and just as its parent company Daiichi Sankyo is pursuing legal action.